CLINICAL TRIALS SUPPORT OFFICE

临床试验支持办公室

基本信息

批准号：
7944789
负责人：
LELAND H HARTWELL
金额：
$ 34.98万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-03-10 至 2013-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7944789
关键词：
Administrative Personnel Area Cancer Center Support Grant Child Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Conduct Clinical Trials Data Development Fee-for-Service Plans Fred Hutchinson Cancer Research Center Goals Growth Housing Institution Location Malignant Neoplasms Medical center Monitor Monitoring Clinical Trials Nursing Research Online Systems Patient Care Patients Pediatric Hospitals Process Protocols documentation Regulation Research Research Infrastructure Research Personnel Research Support Research Training Resources Risk Role Safety Services Southwest Oncology Group Staff Development Training Training Programs Training and Education Universities Visit Washington base clinical practice cost experience lectures meetings member programs research study symposium

项目摘要

The Clinical Trials Support Office (CTSO) was established in 2002 to provide support for clinical researchers at the three Fred Hutchinson/University of Washington Cancer Consortium (Consortium) institutions, which are Fred Hutchinson Cancer Research Center (FHCRC), University of Washington (UW), and Children's Hospital and Regional Medical Center (Children's). The overarching goal of the CTSO is to provide the infrastructure to support the conduct of efficient, high-quality, regulatorycompliant clinical trials within the Consortium. Toward this end, the CTSO provides centralized training and education to Cancer Consortium members and research staff on appropriate conduct of clinical trials. The CTSO also provides, on a fee-for-service basis, research study staff to implement and manage all aspects of clinical trials. The CTSO is responsible for the clinical trials monitoring program and for Protocol-Specific Research Support activities. The key functions of the CTSO are to: 1) Provide experienced, knowledgeable staff to facilitate the implementation and management of clinical trials by Consortium investigators. 2) Provide training services to investigators and research staff in the appropriate implementation and management of clinical trials. 3) Conduct monitoring of ongoing clinical trials as mandated by the Consortium NCIapproved data safety and monitoring plan. 4) Provide expertise, personnel and administrative support for initial development of clinical trials programs within the Consortium, with a special emphasis on young investigators and strategically targeted areas. 5) Optimize resources to maximize cost-effective management of clinical trials.

临床试验支持办公室（CTSO）成立于2002年，为临床试验提供支持 Fred Hutchinson/华盛顿大学三个癌症联盟（联盟）的研究人员机构，包括华盛顿大学 Fred Hutchinson 癌症研究中心 (FHCRC) （华盛顿大学）、儿童医院和地区医疗中心（儿童）。总体目标是 CTSO 旨在提供基础设施来支持高效、高质量、合规的行为联盟内的临床试验。为此，CTSO 提供集中向癌症联盟成员和研究人员提供有关适当进行癌症治疗的培训和教育临床试验。 CTSO 还提供有偿服务的研究人员来实施并管理临床试验的各个方面。 CTSO 负责临床试验监测计划和特定于协议的研究支持活动。 CTSO 的主要职能是： 1) 提供经验丰富、知识渊博的工作人员，以促进联盟研究者实施和管理临床试验。 2）提供培训为调查人员和研究人员提供适当实施和管理的服务临床试验。 3) 按照 NCI 联盟的授权对正在进行的临床试验进行监测数据安全和监控计划。 4) 提供专业知识、人员和行政管理支持联盟内临床试验项目的初步开发，并提供特殊的支持强调年轻研究者和战略目标领域。 5）优化资源最大限度地提高临床试验的成本效益管理。